System for Packaging and Handling an Implant and Method of Use

ABSTRACT

A system designed to store an implant together with the tools necessary to implant the stored implant, and a method of using such system. Such system includes an implant storage tool adapted to retain the implant within a storage container. The implant storage tool is operable to provide an implant applicator.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/206,200, filed Aug. 9, 2011; which application is a continuation ofU.S. application Ser. No. 11/422,815, filed Jun. 7, 2006, now U.S. Pat.No. 7,992,906; which is a continuation of U.S. application Ser. No.11/054,639, filed Feb. 9, 2005, now U.S. Pat. No. 7,128,351; which is acontinuation of U.S. application Ser. No. 10/463,091, filed Jun. 17,2003, now U.S. Pat. No. 6,893,461; which is a divisional of U.S.application Ser. No. 09/843,547 filed Apr. 26, 2001, now U.S. Pat. No.6,581,993; which is a continuation-in-part of U.S. application Ser. No.09/660,371, filed Sep. 12, 2000, now U.S. Pat. No. 6,543,610; alldisclosures of which are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates to a system for packaging, handling andapplying implants. Additionally, this invention relates to a method forintroducing a corneal implant to the corneal surface.

BACKGROUND OF THE INVENTION

Current methods and devices used to store small, delicate, and normallytransparent implants entail free-floating the implant in a volume ofstorage fluid contained within a storage bottle or other container. Thismanner of storage is oftentimes used to preserve retinal transplants,brain tissue transplants, corneal implants, tissue biopsies and anyother delicate biological specimen. Free-floating storage, however,subjects a stored specimen or implant to fluid agitation, which canseverely and irreparably damage the integrity of the stored material. Inaddition, isolating transparent specimens from the storage fluid isdifficult to achieve.

Corneal implants are especially susceptible to the above describedproblem. Corneal implants are used to correct visual disorders such asMyopia or near-sightedness, Hyperopia or farsightedness, Presbyopia ordifficulty in accommodating a change in focus, and Astigmatism. Tocorrect these disorders, the implant is introduced into the body of thecornea in known ways, such as after a flap is formed and an undersurface of the cornea is exposed. The implant, changes the shape of thecornea and alters its refractive power. These implants are generallymade of various types of hydrogels, but can include other polymers,tissue implants, or the like. In the past, storing the corneal implantrequired free-floating the implant in a volume of storage fluidcontained within a storage container. To retrieve the implant, one hadto first locate the implant within the fluid, and then remove theimplant using a filter device or sequestering tool. In the case of acorneal implant, locating the implant is complicated by both the sizeand transparency of the implant. For instance, a corneal implantgenerally has a diameter of about 4.0 to 7.0 mm and a center that isnormally fabricated having a thickness ranging from 25 to 50 microns.Due this minuscule size, physically grasping the implant from thestorage fluid using tweezers, or the like, is simply not practical.

Successful isolation of a corneal implant, or other specimen, generallyrequires the use of a sieve to separate the implant from the fluid.Isolating the implant in this manner, however, subjects the implant tomechanical forces, which could lead to a loss of the implant. If notdamaged, the transparent implant must still be located-on the sievesurface and retrieved. The implant must therefore be grasped usingtweezers, forceps, or the like. Imparting such force upon the implant,however, can also damage the implant. Using force imparting tools tohold the implant is therefore not desirable. Current isolationtechniques are therefore difficult, time-consuming and create additionalsteps, which can also lead to implant contamination. Thus, it is desiredto have an implant storage and handling system, which allows the user torapidly and successfully retrieve the implant for prompt implantation.

Current devices used to deposit an implant onto the cornea surfacegenerally deposit the corneal implant onto the cornea surface in abunched or folded conformation. Aligning the implant in planar relationto the cornea surface requires the surgeon to manipulate or tease theimplant so as to remove any folds or bends in the implant.Problematically, the step of unfolding the implant on the cornea surfacecan cause serious trauma to the cornea surface. This trauma can lead tothe formation of edema, or other deleterious responses that lead torejection or displacement of the implant.

Thus, there is believed to be a demonstrated need for a unitarypackaging and handling system that provides the desired storagecapabilities, easy retrieval of the specimen from that storage, andtools that are operable to retrieve and utilize the specimen withoutcausing damage to the specimen or an implantation site. There is also anadditional need for a more effective method for implanting a cornealimplant onto a cornea surface.

SUMMARY OF THE INVENTION

The present invention relates to an implant packaging and handlingsystem which includes a storage bottle having an opening to receive avolume of implant storage fluid, and an implant holding tool designed toretain the implant in fluid communication with the implant storagefluid. A storage bottle stopper holds the implant holding tool, so thata portion of the implant holding tool is immersed within the storagefluid upon placement of the stopper into the bottle, placing the implantin fluid communication with the storage fluid. The implant holding toolincludes a retaining member detachably mounted to an implant applicatortool. Together they define an enclosure for retaining the implant in asecure, known storage position.

The implant applicator tool has an arcuate-shaped applicator surfacewith a plurality of openings. The arcuate shaped surface is contoured tocorrespond to the curvature of the cornea surface, which aids in theproper implantation of the implant to the cornea surface. In oneembodiment, the applicator surface has one or more recessed surfacesdesigned to hold and center the implant on the applicator surface. Oneor more recessed grooves are also provided to allow fluid to flowbetween the implant and the applicator surface.

The openings have numerous advantages. The openings provide continuousfluid communication between a retained implant and the implant storagefluid. Upon removal from storage, the openings enable the user to unfoldand orient the implant by gently passing fluid through the openings soas to float the implant into a desired central position on theapplicator tool surface. Once so positioned, the user is then able toaspirate the fluid/from between the implant and the applicator tool, theapplicator tool surface. The applicator tool also includes a centralopening providing the user with a reference point for centering theapplicator surface, and thus, the implant onto the surface of thecornea.

The present invention also relates to a method of implanting a cornealimplant using the implant packaging and handling system. The initialstep includes surgically preparing the cornea surface for implantation.Next, the implant and implant holding tool are retrieved from thestorage bottle, and the retaining member removed so as to provide anapplicator tool together with implant. The applicator can then beattached to a handle for ease of use. The implant is then properlyaligned on the applicator tool and deposited onto the surgicallyprepared cornea surface. Finally, the cornea is restored.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the invention can be obtained from thedetailed description of exemplary embodiments set forth below, whenconsidered in conjunction with the appended drawings, in which:

FIG. 1 is a partial sectional view of the implant packaging and handlingsystem of the present invention;

FIG. 2 is a schematic representation of the implant applicator toolfastened to a retaining member, providing the implant storage tool ofthe present invention;

FIG. 3 is a schematic representation of the implant applicator tool ofthe present invention;

FIG. 4 is a schematic representation of the retaining member adapted toform an implant retaining enclosure when fastened to the implantapplicator tool of FIG. 3;

FIG. 5 is a bottom view of a stopper used to seal the storage bottle ofthe present invention, showing the implant storage tool engagement slotin an open position;

FIG. 6 is a cross-sectional view through the stopper of FIG. 5 taken online 10-10;

FIG. 7 is a partial sectional view of the bottle stopper positionedwithin the storage bottle, showing the implant storage tool engagementslot in a closed position;

FIG. 8 is a cross-section at view through the stopper and storage bottleof FIG. 7 taken on line 20-20;

FIG. 9 is a schematic illustration of the implant applicator toolsecured to a handle;

FIG. 10 is a side view of the implant applicator tool secured to ahandle, showing the curved surface of the implant applicator tool, whichcorresponds with the contour of the cornea surface;

FIG. 11 is a schematic representation of an implant applicator toolhaving a central opening for aligning the applicator tool with thevisual or pupillary axis of the eye;

FIG. 12 is a schematic representation of an implant applicator toolhaving a recessed surface defining a central opening and adjacentalignment slot;

FIG. 13 is a schematic representation of a retaining member adapted toengage with the applicator tools shown in FIGS. 9 and 12, and FIG. 13 ashows the retaining member in a planar configuration, i.e., before tabs26 and 28 have been folded down as shown in FIG. 13;

FIGS. 14 a, 14 b, 14 c, 14 d and 14 e are cross-sectional views of ahuman eye illustrating the method of introducing an implant to thecornea surface using the implant applicator tool of the presentinvention;

FIG. 15 a is a side view of the presently preferred embodiment ofimplant packaging and handling system of the present invention;

FIG. 15 b is a cross-sectional view of the implant packaging andhandling system shown in FIG. 15 a illustrating the relation between theupper lens carrier member and the lower lens support member;

FIG. 16 a is a top view of the upper lens carrier member of the implantpackaging and handling system of the present invention;

FIG. 16 b is a side view of the upper lens carrier member of the implantpackaging and handling system of the present invention;

FIG. 16 c is a cross-sectional view across line B-B of the upper lenscarrier member shown in FIG. 16 a;

FIG. 17 a is a top view of the lower lens support member of the implantpackaging and handling system of the present invention;

FIG. 17 b is a side view of the lower lens support member of the implantpackaging and handling system of the present invention;

FIG. 17 c is a cross-sectional view of the lower lens support membershown in FIGS. 17 a and 17 b;

FIG. 18 is a top view of a lens implant of the present invention showingan asymmetrical mark for proper orientation of the lens on the corneasurface;

FIG. 19 is a top view of a lens implant of the present invention showingasymmetrical markings for proper orientation of the lens on the corneasurface;

FIG. 20 is a top view of a lens implant of the present invention showingthe posterior surface of the lens implant having the letter “a”imprinted on the anterior surface.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIGS. 1-17 b of the drawings show an implant packaging and handlingsystem 10 of the present invention. As illustrated in FIG. 1, thepreferred system 10 includes a cylindrical storage bottle 11 for holdingimplant storage fluid (not indicated). The bottle 11 is sealed by astopper 12 having an upper cap portion 14 and a plug portion 13, whichis adapted to detachably couple to an implant storage tool 15. Aprotective safety seal 17 provides tamper resistance and maintains thestopper 12 in sealed relation to the bottle 11.

FIGS. 2-4 show a retaining member 16 and implant applicator tool 19,which together define the implant storage tool 15. As illustrated, theretaining member 16 is adapted to detachably engage the implantapplicator tool 19, thereby defining an enclosure 41 operable to retainthe implant. Both the retaining member 16 and the applicator tool 19include a plurality of openings 18 and 22, respectively, which allowstorage fluid to communicate into the implant retaining enclosure 41. Asshown in FIG. 1, the implant retaining enclosure 41 is located on theend of storage tool 15 that is distal to the stopper 12 such that theenclosure 41 is immersed in implant storage fluid when the storage tool15 is inserted into the bottle 11. When the implant is stored, theenclosure 41 of storage tool 15 holds the implant in the storage fluid,while also providing a user with ready access to the implant. The usersimply removes the stopper 12, thereby removing the storage tool 15 fromthe bottle 11, and detaches the retaining member 16 from the applicator19 to access the implant.

As illustrated in FIG. 3, applicator tool 19 has a handle attachment arm20 connected through a body portion 21 to an implant applicator member45. The body portion 21 is preferably shaped to provide a broad handlingsurface. For instance, FIGS. 2 and 3 show a body portion 21 having abroad elliptical shape, which allows a user to more easily manipulatethe applicator tool 19. As shown, the implant applicator member 45includes an applicator surface 42 having a plurality of openings 22 toprovide fluid communication between the applicator surface 42 and animplant resting thereon. Openings 22 further allow the user to releasethe implant from the applicator surface 42. More particularly, the usercan impart force upon the implant by passing through the opening 22either a flow of fluid or a cantilever so as to forcibly separate theimplant from the applicator member surface 42 (as is shown in FIG. 14).

In a preferred embodiment, the applicator surface 42 has a centralopening 23 to help the user align the applicator surface 42 along thevisual or optical axis of the eye. As shown, the centrally positionedopening 23 defines a circular opening having a diameter greater than thediameter of the surrounding openings 22. In this way, the user isprovided with a central point of reference, which enables the user toalign the applicator surface 42 with the optical axis of the eye, andthus, properly position the implant.

In another embodiment, the applicator tool 19 may include an applicatoralignment notch 24 positioned integral to the surface 42 of theapplicator member 45. For instance, FIGS. 3 and 12 show the notch 24extending inwardly towards the centrally positioned alignment opening23. In this embodiment, the notch 24 is used to align the implant on thecornea surface 39, as well as release the implant from the applicatorsurface 42. Specifically, the notch 24 is dimensioned to allow acantilever, or like instrument, to pass through the notch, therebyallowing the user to impart force against an implant held on theapplicator surface 42. Specifically, the user lifts the application tool19 away from the cornea surface while simultaneously imparting downwardforce on the implant through the notch 24 so as to release the implant.One skilled in the art will understand that various notch positioningscan be incorporated into the applicator member 45 without departing fromthe scope of the present invention.

As shown in FIG. 2, the retaining member 16 has an outer surface 44defining a plurality of openings 18 that provide fluid communication toan implant retained by the enclosure 41. FIG. 4 shows a retaining member16 disengaged from the applicator tool 19 shown in FIG. 3. To secure theretaining member 16 to the applicator tool 19, the retaining member 16is provided with attachment tabs 26 a-c adapted to insert intocorresponding attachment slots 25 a-c integral to the applicator tool19. In use, the retaining member 16 is attached to the applicator tool19 by simply inserting the tabs 26 a-c into the respective correspondingslots 25 a-c, and then positioning the bottom surfaces 28 of retainingmember side walls 43 against the applicator surface 42. In a preferredembodiment, at least one side wall 43 has an overlapping flexibleportion 27 adapted to bend about the distal edge of the applicatorsurface 42, thereby securely clamping the retaining member 16 to theapplicator tool 19. To remove the retaining member 16, the user merelyunclamps the flexible portion 27 by bending it away from the applicatortool 19, and lifting the member 16 so as to disengage tabs 26 a-c fromslots 25 a-c.

As illustrated in FIGS. 9, 11, 12 and 13, an alternative attachment tab26 and attachment slot 25 can also be used with the present invention.For instance, FIG. 12 shows an applicator tool 19 having four separateattachment slots 25, while in comparison FIG. 3 shows an applicator tool19 having three separate attachment slots 25 a-c. It will be understoodby those skilled in the art that various embodiments for attachmentslots 25 and tabs 26 can be incorporated into the applicator tool 19 andretaining member 16 without deviating from the scope of the presentinvention.

As illustrated in FIGS. 5-8, a preferred embodiment of system 10includes a bottle stopper 12 adapted to receive and securely hold thehandle attachment arm 20 of the applicator tool 19. The stopper 12preferably includes an upper cap portion 14 and a plug portion 13dimensioned to insertably seal the bottle 11. FIG. 5 shows the stopperplug portion 13, which is not inserted into a storage bottle opening 46(shown in FIG. 8). In comparison to FIG. 5, FIG. 7 shows the plug 13inserted into the storage bottle opening 46. As illustrated by FIGS. 5and 7, plug portion 13, when removed from bottle opening 46, adopts anelliptical shape by distending in an outwardly direction along line the10-10. Likewise, inserting stopper 12 into bottle opening 46 causes theouter diameter of plug portion 13 to conform to the inner diameter ofthe inner bottle surface 34. In this way, the plug portion 13 becomesinwardly compressed along line 30-30. Referring to FIGS. 6 and 8,cross-section views are shown of stopper plug portion 13 in anout-of-bottle elliptical shape and an in-bottle compressed circularshape, respectively. The utility of this embodiment is described in moredetail below.

An engagement slot 32 is located integral to plug portion 13 in anorientation perpendicular to line 10-10. As illustrated in FIGS. 5-8,the engagement slot 32 opens or closes in response to either the removalor insertion of the plug portion 13 from the bottle opening 46,respectively. Referring to FIGS. 5 and 6, the engagement slot 32 isshown in an open position. More particularly, when the user removes thestopper 12 from bottle opening 46, the plug portion 13 adopts anunrestrained elliptical shape by distending outwardly along the line10-10 for opening slot 32. In this way, the engagement arm 20 of theapplicator tool 19, which is held by the engagement the slot 32, iseasily separated from slot 32 once the stopper 12 is removed from thestorage bottle 11. By way of comparison, FIGS. 7 and 8 show theengagement slot 32 adopting a closed conformation upon insertion of thestopper 12 into the bottle opening 46. As shown in FIG. 7, insertion ofthe stopper 12 into the bottle 11 causes the outer surface 47 of theplug portion 13 to conform to the inner diameter of the bottle openingsurface 34, which imparts force in the direction of the line 30-30. Inthis way, the slot 32 is forced into a tight, closed conformation. Thus,the engagement arm 20 of the applicator tool 19 is held by a slot 32 ina secure position when the stopper 12 is inserted into the bottle 11.The stopper 12 is preferably made of silicone rubber, or otherelastomeric material.

FIGS. 9 and 10 show an applicator tool 19 attached to a handle 30. Theapplicator tool attachment arm 20 detachably mounts to the handle 30through a handle fastener 31. It will be understood by those skilled inthe art that numerous types of handles and handle fasteners areavailable that can be used with the applicator tool 19 without departingfrom the scope of the present invention.

As illustrated by FIG. 10, the implant applicator member 45 has a curvedapplicator surface 42, which corresponds to the curvature of the corneaimplant site. This curved surface allows the user to position the curvedapplicator surface 42 evenly across the cornea surface, enabling theimplant to be more evenly deposited onto the cornea surface. Referringto FIGS. 9 and 12, each applicator member 45 is shown having a recessedapplicator surface 29. As shown, the recessed surface 29 is preferablycircular, thereby allowing a substantially circular implant to becentrally positioned on the applicator member 45. In addition, thecentral opening 23 which is centered relative to the perimeter of thecircular recess 29, provides the user with a reference point foralignment of the applicator member 45 with the pupil diameter. In thisway, the implant can be properly aligned on the cornea surface.

FIG. 11 shows an applicator tool 19 having an applicator surface 42 withrecessed grooves 29 to allow fluid to flow between the applicatorsurface 42 and an implant supported on the surface 42. It should beunderstood by one skilled in the art that alternatively dimensionedrecesses and grooves can be formed in the applicator surface 42 withoutdeparting from the scope of the present invention. It is advantageous toprovide fluid flow between the surface 42 and the implant to enable theuser to more easily manipulate the implant while it is on the applicatorsurface 42. During storage, for example, the implant may come to rest invarious folded and bunched conformations. Once the retaining member 16is removed, the user can manipulate the implant into its desiredconformation by gently passing a volume of fluid through the openings 22and 23. More particularly, the implant will overlap a small volume offluid, thereby allowing the user to floatingly realign the implant onthe applicator surface 42. After the implant is aligned, the fluid canbe removed by simply touching the underside of the applicator member 45with a cotton swab, or like absorbent material.

FIGS. 12 and 13 show an alternative embodiment of an applicator tool 19and a retaining member 16, respectively. In this embodiment, theretaining member 16 includes four attachment tabs 26 that detachablyinsert into four corresponding applicator tool attachment slots 25. Asshown, the tool 19 and the retaining member 18 include fluidcommunication openings 22 and 18, respectively. It should be understoodthat various combinations of tabs, slots, alignment and openings can beincorporated into the tool 19 and the member 16 without deviating fromthe scope of the present invention.

FIGS. 14 a-14 e illustrate the steps of the claimed method of implantingan implant to an exposed surface of the cornea using the system of thepresent invention. The first step, shown in FIG. 14 a, involves thesurgical preparation of a portion of the outer surface of the cornea 38of the eye to form a corneal flap 37, which remains attached to thecornea 38 by way of a hinge 36. This surgical step is commonly known inthe art as a lamellar dissectomy, and is typically performed using akeratome (not shown). In a preferred embodiment, the flap is cut deeplyenough to dissect the Bowman's membrane portion of the cornea 38.Surgically preparing a corneal flap of 100 to 200 microns, typically 160to 180 microns, operates to eliminate tension caused by the Bowman'smembrane. This step reduces the possibility of implant extrusion due topressure generated within the cornea 38, which may be caused by theimplant. As illustrated, it is preferable to leave the corneal flap 37attached by way of a hinge 36, thereby allowing the flap 37 to bereplaced in the same orientation as before the cut.

After the surface 39 is prepared, the surgeon deposits the implant 40onto the surface 39 using the applicator 19. To retrieve the applicatortool 19, the surgeon first removes the protective seal 17 from aroundthe bottle opening. The implant holding tool 15 is then removed fromwithin the bottle 11 by removing the stopper 12, which holds the storagetool 15. The storage tool 15 is easily separated from the stopper 12 byholding the tool 15 about the body portion 21 and disengaging the tool15 from the now opened slot 32. Next, the tool arm 20 can be attached toa handle 30, and the retaining member 16 removed. Removing the member 16presents the implant 40 to the surgeon for implantation. The surgeon isable, therefore, to retrieve an implant 40 from a storage bottle 11without having to use, at the risk of damaging or losing the implant, agrasping tool, such as tweezers or surgical forceps.

The surgeon then properly aligns the implant 40 on the applicatorsurface 42 by preferably passing liquid through the openings 22. At thisstep, the surgeon may gently guide the implant 40 to its properalignment on the surface 42 using a cannula 35, or other similar device.The implant 40 is positioned on the applicator surface 42 by drawing offthe fluid located intermediate to the implant 40 and the applicatorsurface 42. This can be done by placing a cotton swab, or otherabsorbent material, against the underside of applicator member 45, whichdraws off the fluid through openings 22.

As shown in FIG. 14 b, the corneal flap 37 is pulled away from thecornea implantation surface 39. The implant 40 is then positioned overthe cornea implantation surface 39 by holding the applicator tool 19 ina generally horizontal position over the surface 39 with the implant 40facing the surface 39. As shown, the applicator member 45 has an arcuateshaped applicator surface 42, which matches the curved shaped of thecornea surface 39. In this way, as illustrated in FIG. 14 c, theapplicator member 45 can be evenly placed over the cornea surface 39,reducing trauma to the surface 39. Specifically, the implant 40 isevenly adhered to the surface 39, reducing the need for any manipulationof the implant 40 on the surface 39, which could traumatize the eye asis described above.

Referring to FIG. 14 d, the implant 40 is deposited onto the surface 39by gently lifting the applicator tool 19 away from the surface 39. Asshown, the implant 40 remains adhered to the surface 39. The use of acannula 35 operable to pass a volume of fluid flow through opening 22,however, can be used to ensure proper deposition of the implant 40 ontosurface 39. As shown in FIG. 14 e, once the implant is deposited ontothe surface 39, the corneal flap 37 is replaced.

As shown in FIGS. 15 a-19, there is illustrated a presently preferredembodiment for an implant packaging and handling system 48 used to applya corneal implant to the corneal surface. Referring to FIG. 15 a, thepreferred embodiment includes an implant carrier member 80 having ahandle portion 50 joined at an angle to a implant applicator portion 58.The system 48 further includes an implant carrier member 80, which isspecially contoured to detachably connect to the implant support member78. As illustrated, the implant support member 78 is also provided witha handle portion 52 joined at an angle to an implant support portion 56.

As illustrated in FIG. 15 b, fastening the carrier 80 and support 78members together operably aligns the implant applicator portion 58 andimplant support portion 56. In this embodiment, the handle portions 50and 52 are adjacently positioned so as to form a support handle 54having an end 96 that is held within by an opening 32 in a vial stopper12 during storage conditions, as illustrated by FIG. 1. In this way, theconcave surface 70 of the applicator portion 58 overlaps the upperimplant support surface 76, which is preferably a convex surface, of thesupport portion 56. This overlapping arrangement forms a chamber 88between the two surfaces, 70 and 76, which provides a storage space tohold an implant therein.

Referring to FIG. 16 c, which is shown a cross-sectional view of thepreferred implant applicator portion 58. The applicator portion 58includes a recessed or domed portion having an upper surface 86 andlower surface 70. The lower surface 70 is specially contoured to have aradius of curvature that is greater than the radius of curvature of animplant that is being packaged. Such design is advantageous in assistingwith the release of the lens implant from the applicator surface 70.More particularly, a corneal implant generally includes a posteriorsurface that is applied directly to the corneal surface and an anteriorsurface that is covered by a corneal flap following the application ofthe implant to the corneal surface. Similar to the method described indetail above, applying the implant to the corneal surface is achieved bysetting the applicator surface 70 of the applicator portion 58 incontact with the corneal surface and then lifting the applicator portion58 away from the corneal surface, wherein the anterior surface of theimplant remains adhered to the corneal surface and the posterior surfaceof the implant releases from the applicator surface 70. To both enhancedeposition of the implant onto the corneal surface and prevent theimplant from remaining adhered to the applicator lower surface 70, theapplicator lower surface 70 is provided with a radius of curvature thatis greater than the curvature of the anterior surface of the particularimplant that is packaged and held in the chamber 88 between the implantapplicator portion 58 and the support portion 56. In this way, theanterior surface of the implant and the applicator lower surface 70 arenot complementary, and, thus, are more easily separated.

In another embodiment, the applicator surface 70 is provided with anindented ring or recessed applicator surface (as is shown in FIG. 12 andindicated by numeral 29). The recessed surface is preferably circular,thereby allowing a substantially circular implant to be centrallypositioned on the applicator surface 70.

To further enhance displacement of the implant from the applicatorsurface 70, a plurality of openings 64 are provided through theapplicator surface 70 through which a volume of fluid can be passed orwithdrawn away from the implant resting against the applicator surface70. Particularly, the openings 64 provide a fluid passage for drawingfluid away from the implant using a cotton swab, or other absorbentmaterial, placed against the upper surface 86 of the applicator portion58. Additionally, a central opening 66 is provided on the applicatorsurface to assist with the proper alignment of the implant and thedeposition of the implant onto the cornea surface. Specifically, acannula or like instrument can be inserted through the central opening66 to depress and assist the release of the implant from the applicatorsurface 76, as is described in greater detail above. As is alsodescribed above, the central opening 66 defines a circular openinghaving a diameter greater than the diameter of the surrounding openings64. In this way, the user is provided with a central point of reference,which enables the user to align the applicator surface 70 with theoptical axis of the eye, and, thus, properly position the implant.

Referring to FIGS. 17 a-17 c, there is shown the implant support member78. As illustrated, the implant support member 78 has a handle portion52 joined to an implant support portion 56. The implant support portion56 comprises a platform portion 82 disposed about an upper implantsupport surface 76 having an opposing lower surface 90 that is recessedrelative to the lower surface of the platform portion 82. The support 76and lower 90 surfaces define a plurality of openings therethrough tofacilitate the passage of liquid to and away from the implant.

Referring to FIG. 16 b the support portion 56 is shown as beingangularly connected to the handle portion 52. In the present embodiment,it is advantageous to provide an angle between the handle portion 52 andthe lower surface of the platform portion 52 of between about 30° andabout 60°. Likewise, and as illustrated in FIG. 17 b, the angularconnection between the applicator portion 58 and handle portion 50 formsis generally between about 30° and about 60° relative to the lowersurface of platform portion 84. A preferable angular connection betweenthe handle portions 50 and 52 and platform portions 84 and 82,respectively, is about 45°. Though preferred angles are provided, it isto be understood that a range of angular connections can be used withoutdeviating from the scope of the present invention.

Referring to FIGS. 15 b, 16 a and 17 a, there is illustrated a preferredembodiment to maintain the implant support member 78 detachablyconnected to the implant carrier member 80. Specifically, as illustratedby FIG. 16 a, the carrier member 80 is provided with a pair of notchesor grooves, 68 a and 68 b, along opposite edges of the carrier member80. More particularly, the notches or grooves, 68 a and 68 b, arelocated on opposite sides of the implant applicator portion 58.Likewise, the support member 78 is provided with a pair of notches orgrooves, 68 c and 68 d, located on opposite sides of the implant supportportion 56 of the support member 78. In this way, the carrier member 80can be securely fastened to the support member 78 by aligning notch 68 awith 68 c, and 68 b with 68 d, and then positioning a fastening meansabout the two members and securely within the matched notches. Referringto FIG. 15 b, a fastening means can include an elastic band 69, which isplaced about each member, 78 and 80, and secured within each of therespective notches (68 a-d) to secure the members together in adetachable manner. Alternatively, metal or plastic clips could be usedto fasten together the two members, 78 and 80. It should be understood,however, that various ways can be utilized to fasten the two memberstogether in a detachable manner without deviating from the scope of thepresent invention.

Referring to FIG. 17 a, a preferred embodiment of the present inventioncomprises a space or slot 74 through the handle portion 52 of thesupport member 78 for receiving and interlocking with a tab portion 72.As shown in FIG. 16 b, there is illustrated a tongue or tab portion 72extending from the lower surface of the handle portion 50 of the carriermember 80. In use, the carrier member 80 is positioned in overlappingrelation to the support member 78 such that the tap portion 72 isinserted into the slot 74. Once inserted, the tab portion 72 holds thecarrier member 80 together with the support member 78. To providefurther attachment, the band 69 is then place about the implantapplicator portion 58 and implant support portion 56, as is described inmore detail above. In its preferred use, the user initially removes theband 69 or other attachment means from about the adjacently fastenedmembers, 78 and 80. Once removed, the user simply slides the handleportion 50 in the direction indicated by the arrow 98 or other similarindicia. In this way, the tab 72 is slidably disengages from the slot 74and the two members, 78 and 80, are separated. Once separated, the topcarrier member 80 is used to apply the implant to the cornea surface.The handle portion 50 of the carrier member 80 can be attached to asurgical-style handle 30 as illustrated in FIGS. 9 and 10. The user isthen able to easily manipulate the carrier member 80 for depositing theimplant onto the cornea surface.

Because of the special design of the support surface 76, the lensimplant will preferably remain adhered to the carrier applicator surface70 on the carrier member 80 upon separation of the two members, 78 and80. More particularly, a preferred embodiment for the support surface 76comprises fabricating the surface 76 to have a more uneven or roughcontour than the adjacent applicator surface 70. Specifically, theapplicator surface 70 is provided as a smooth or polished surface, whilethe support surface 76 is provided as a more rough or uneven surface 76.In this embodiment, it is not critical that the surface 70 bemicroscopically smooth, though it is preferred; however, it is criticalthat the surface 70 be more smooth than the corresponding supportsurface 76. In this manner, the applicator surface 70 provides asmoother surface area for directly contacting and adhering to the lensimplant. The support surface 76, however, is preferably fabricated so asto have a contour characterized by minute bumps or rounded portionsalong the surface 76. This contoured surface can be fabricated bymanufacturing the support surface 76 from polypropylene comprisingpolytetrafluoroethylene beads embedded in the polypropylene surface.Polytetrafluoroethylene is sold under the trade name TEFLON. In thisembodiment, the beads maintain their general conformation when embedded,which results in the surface 76 having raised bumps, rounded portions,or the like. Alternatively, the support surface 76 can be roughened,etched, notched, scored or made to be imperfect using any one ofmolding, stamping or other mechanical techniques generally known in theart. In this way, the surface 76 is less able to adhere to the surfaceof the implant than is the more smooth applicator surface 70, and theimplant will preferentially remain adhered to the applicator surface 70upon separation of the two members, 78 and 80.

As described above, the implant can be further directed to maintain anadhering position on the applicator surface 70 by removing the system 48from the storage bottle 11 and turning the system 48 such that thecarrier member 80 is facing downwards. Next, the user simply places anabsorbent material against the top surface 60 of the applicator portion58 so as to draw fluid from within the chamber 88 through the openings64. This results in the implant being lowered to a resting positionagainst the applicator surface 70 as the storage fluid is withdrawn fromthe chamber 88.

In another presently preferred embodiment, one or more of the variousmembers of the system 48 is made from a polymer or plastic material. Forinstance, the system 48 components could be made from one or acombination of the following polymers: Polytetrafluoroethylene (soldunder the trade name TEFLON), Polypropylene, or Polysulfone (sold underthe trade name UDEL). Alternatively, portions of each component membercould be made from a polymer or plastic together with a portioncomprising stainless steel or other metal or semi-metal material. Forinstance, the handle portion 50 of the implant carrier member 80 couldbe manufactured from stainless steel, and the applicator portion 58could be manufactured from a polymer material. The handle and applicatorportions could then be welded or interlocked together using variousfabrication techniques known in the art. It should also be understoodthat various other polymers or polymer combinations can be utilizedwithout deviating from the scope of the present invention.

As described above, the present system 48 is used to maintain an implantin a hydrated condition during storage and shipping. More particularly,and as is shown in FIG. 15 a, the handle portions 50 and 52 of eachmember when positioned together form a support handle 54 adapted toinsert into a vial stopper. As described above, and illustrated in FIGS.5-8, a means for holding the system 48 in a storage vial comprisesinserting the end 96 of the support handle 54 into an opening 32provided in a stopper 12. Once inserted into the opening 32, the stopper12 is placed in the vial opening thereby positioning the implant withinthe vial and in contact with a volume of storage fluid in the vial. Itshould be understood that the presently described system 48 for holdingand applying the implant to the corneal surface is readily adapted foruse with the storage vial and stopper described in more detail above. Inthis way, the implant is contained within the chamber 88 and maintainedin a hydrated condition by the passage of fluid through the respectiveopenings 62, 64 and 66.

In the present embodiment, the lens implant 92 is packaged within thechamber 88 defined by the applicator surface 70 and carrier supportsurface 76. It is to be understood that the height of this space isdesigned to be sufficiently narrow that the implant 92 remains properlyoriented within the chamber 88 during storage and handling conditions.In this way, the user simply detaches the upper implant member 80 fromthe implant support member 78 and deposits the implant to the cornealsurface by placing the applicator surface 70, on which the implant isadhered to, directly to the corneal surface. To ensure that the implantis properly oriented, however, the implant is provided with specialasymmetric markings, which the user views to make a determination thatthe implant is resting against the corneal surface in a properorientation. Referring to FIGS. 18-20, there are shown three exemplaryembodiments of asymmetric markings 94 that can be utilized to properlyorient the lens implant. As shown by FIGS. 18 and 19, the markings arepreferably positioned in a clockwise orientation. In another embodiment,shown in FIG. 20, a letter can be placed on the posterior surface of theimplant. In this way, if the implant's posterior surface is placed ontothe cornea surface, then the letter will not read properly. Forinstance, FIG. 20 shows the letter “a” on the posterior surface of theimplant 92. If the implant 92 is not positioned right side up on thecornea surface, then the letter will read backwards. In this embodiment,any letter can be used so long as it has an asymmetric design. Forinstance, “R”, “P”, “C”, etc. It is to be understood, however, thatother symmetrical or asymmetric markings and orientations can be usedwithout deviating from the scope of the present invention.

In this embodiment, the markings 94 can be positioned onto the lensusing laser engraving, and/or printing with ink. Alternatively, openingsthrough the lens can be asymmetrically positioned about the lens. It isimportant, however, that the markings 94 be positioned as far from theoptical zone as possible to prevent optical distortion. It is to befurther understood that various methods and techniques for placing themark on the lens can be used without deviating from the scope of thepresent invention. For instance, notches could be positioned in anasymmetric orientation about the edge of the lens implant.

In another embodiment, the system 48 is provided as a component of a kitused to store, handle and implant the implant onto the cornea surface.Specifically, the system 48 is provided within a storage bottle (asillustrated above in FIG. 1) having a volume of storage fluid containedtherein. In this way, the handle end 96 is inserted into the opening 32(FIG. 5) in the stopper, and the stopper is placed into the bottle 11,which positions the implant holding chamber 88 located opposite thehandle end 96 within the bottle. In this way, the implant 92 ispositioned in communication with the storage fluid. The implant 92 isprovided having the markings 94 shown in FIGS. 18 and 19 to assist theuser with properly orienting and/or to ensure that the implant ispositioned right side up on the cornea surface.

Various embodiments of the present invention have been described herein.It should be understood by those of ordinary skill in the art, however,that the above described embodiments of the present invention are setforth merely by way of example and should not be interpreted as limitingthe scope of the present invention, which is defined by the appendedclaims. Many other alternative embodiments, variations and modificationsof the foregoing embodiments that embrace various aspects of the presentinvention will also be understood upon a reading of the detaileddescription in light of the prior art. For instance, it will beunderstood that features of one embodiment may be combined with featuresof other embodiments while many other features may be omitted (orreplaced) as being nonessential to the practice of the presentinvention.

1. A corneal implant applicator apparatus, comprising: a cornealimplant; and an applicator comprising a handle and an applicator member,the applicator member comprising an applicator surface adapted tointeract with the corneal implant, wherein the applicator surface isconfigured such that the corneal implant has a greater preference foradhering to corneal tissue than to the applicator surface.
 2. Theapparatus of claim 1 further comprising a support member comprising asupport surface, wherein the support surface is adapted to interact withthe applicator surface to form an enclosure in which the corneal implantis disposed, wherein the support surface is configured such that thecorneal implant has a greater preference for adhering to the applicatorsurface than to the support surface.
 3. The apparatus of claim 2 whereinthe support member is movable relative to the applicator member toprovide access to the corneal implant.
 4. The apparatus of claim 3wherein the support member is detachably coupled to the applicatormember to provide access to the corneal implant.
 5. The apparatus ofclaim 3 further comprising at least one clip adapted to couple thesupport member to the applicator member.
 6. The apparatus of claim 2wherein the support surface has a contour different than a contour ofthe applicator surface, wherein the different contours provide thecorneal implant with the greater preference for adhering to theapplicator surface than to the support surface.
 7. The apparatus ofclaim 1 wherein an angle between about 30 degrees and about 60 degreesexists between the handle and the applicator portion.
 8. The apparatusof claim 1 wherein the applicator surface has a radius of curvature thatis greater than the radius of curvature of the posterior surface of thecorneal implant.
 9. A method of depositing a corneal implant ontocorneal tissue, comprising: providing a corneal implant applicatorapparatus, the apparatus comprising an applicator comprising a handleand an applicator member comprising an applicator surface, and a cornealimplant engaging the applicator surface; positioning the applicatorapparatus such that the corneal implant engages corneal tissue; movingthe applicator surface away from the corneal tissue to allow the cornealimplant to preferentially adhere to the corneal tissue over theapplicator surface, thereby depositing the corneal implant on thecorneal tissue.
 10. The method of claim 9 wherein the providing stepcomprises providing a corneal implant applicator apparatus that alsocomprises a support member comprising a support surface adapted tointeract with the applicator surface to form an enclosure in which thecorneal implant is disposed, the method further comprising moving thesupport member relative to the applicator member to provide access tothe corneal implant, wherein moving the support member occurs before thepositioning step.
 11. The method of claim 10 wherein moving the supportmember relative to the applicator member comprises allowing the cornealimplant to preferentially adhere to the applicator surface over thesupport surface.
 12. The method of claim 10 wherein moving the supportmember relative to the applicator member comprises detaching the supportmember from the applicator member.
 13. The method of claim 10 furthercomprising wicking away fluid from within the enclosure, wherein thewicking step occurs prior to moving the support member relative to theapplicator member to provide access to the corneal implant.
 14. Themethod of claim 9 further comprising creating a corneal flap, liftingthe corneal flap to expose a corneal bed, and wherein the depositingstep comprises depositing the corneal implant on the corneal bed.